Navelbine Is Now Available for Use in Inoperable Advanced Stage NSCLC

February 1, 1995

RESEARCH TRIANGLE PARK, NC--Navelbine (vinorelbine tartrate), a semisynthetic vinca alkaloid, has become the first new treatment to receive FDA approval for inoperable advanced non-small-cell lung cancer (NSCLC) in 20 years, Burroughs Wellcome Co., manufacturer of Navelbine, announced at a telephone news conference.

RESEARCH TRIANGLE PARK, NC--Navelbine (vinorelbine tartrate),a semisynthetic vinca alkaloid, has become the first new treatmentto receive FDA approval for inoperable advanced non-small-celllung cancer (NSCLC) in 20 years, Burroughs Wellcome Co., manufacturerof Navelbine, announced at a telephone news conference.

Single Agent or Combination

Specifically, the drug is licensed for use in ambulatory stageIII and IV patients, to be used as either a single agent or incombination with cisplatin (Platinol) in stage IV patients, andonly in combination in stage III patients.

"Although it is not a cure, Navelbine is an important advancein treatment options, potentially prolonging life, with more manageableside effects than other commonly used chemotherapy agents,"said Richard Tuttle, PhD, director of cancer therapy at BurroughsWellcome.

The agent was developed by Pierre Fabre Medicament in France,where it is marketed for NSCLC and advanced breast cancer, andhas been developed for use in North America by Burroughs Wellcomeunder a licensing agreement with Pierre Fabre, Dr. Tuttle said.

Richard Gralla, MD, director of the Ochsner Cancer Institute,said that the agent is well tolerated on an outpatient basis,"allowing patients to pursue their normal activities."He noted that Navelbine generally does not cause nausea, and ifit does occur, it is easy to treat or prevent. Alopecia and peripheralneuropathy are also uncommon.

In two major controlled trials involving more than 800 advancedNSCLC patients, Navelbine increased survival when used as a singleagent or in combination with cisplatin. In a large European trial,those receiving the combination had a median survival of 40 weeks,compared with 31 weeks for patients treated with Navelbine alone,and 32 weeks for those treated with cisplatin and vindesine, acommon regimen in Europe.

"While this benefit is a modest one, when viewed in the contextof patients receiving standard supportive care and no chemotherapy,the Navelbine/cisplatin combination produces a two- to threefoldincrease in survival, with about three times as many patientsliving for over a year," Dr. Gralla said.

Cynthia Rittenberg, RN, director of oncology nursing research,Ochsner Cancer Institute, noted that Navelbine is easy to give,with the actual infusion taking only 6 to 10 minutes. "Whenpatients know that it's likely they will not be cured, their prioritiesoften change. They come for treatment to try to live longer andto live better," she said. For these patients, the extraweeks of life achieved with Navelbine can be significant.

"We can't promise every patient a response with Navelbine,but we can say that for those who do respond, almost all maintaina reasonable quality of life," Ms. Rittenberg said.

In response to a question from a conference participant, StevenMunshower, vice president of communications at Burroughs Wellcome,said that the cost of Navelbine treatment is approximately $250per week and that a company hotline is available for physiciansand patients seeking advice on reimbursement. (Call 1-800-423-6869.)

Dr. Tuttle noted that the company has submitted an NDA for useof Navelbine in advanced breast cancer, and that clinical trialsare also being done with Navelbine in ovarian and prostate cancers,with trials in early stage III NSCLC just getting under way.

Dr. Gralla added that a small investigational study at the OchsnerCancer Institute in which Navelbine and cisplatin are being givenpreoperatively to patients with stage IIIa NSCLC has shown earlyencouraging results, with a high resection rate after chemotherapyand encouraging effects on survival in the initial evaluation.